Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, 78249-78251 [2010-31380]
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Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
building no later than 9 a.m. e.s.t. to
allow for enough time to clear security
and to check in before the meeting
begins. The on-site check-in for visitors
will begin at 9:30 a.m. e.s.t. All items
brought to the building, whether
personal or for the purpose of
demonstration or to support a
presentation, including items such as
laptops, cell phones, and palm pilots,
are subject to physical inspection.
Security measures include the
following:
• Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
• Interior and exterior inspection of
vehicles (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
• Passing through a metal detector
and inspection of items brought into the
building.
We note that all items brought to
CMS, whether personal or for the
purpose of demonstration or to support
a demonstration, are subject to
inspection. We cannot assume
responsibility for coordinating the
receipt, transfer, transport, storage,
setup, safety, or timely arrival of any
personal belongings or items used for
demonstration or to support a
demonstration.
Note: Individuals who are not registered in
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meeting. The public may not enter the
building earlier than 45 minutes prior to the
convening of the meeting. All visitors must be
escorted in areas other than the lower and
first floor levels in the Central Building.
Seating capacity is limited to the first 250
registrants.
Authority: Section 503 of Public Law 108–
173.
hsrobinson on DSK69SOYB1PROD with NOTICES
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program).
Dated: December 7, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2010–31301 Filed 12–13–10; 8:45 am]
BILLING CODE 4120–01–P
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19:10 Dec 14, 2010
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0008]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Citizen Petitions and
Petitions for Stay of Action Subject to
Section 505(q) of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
DATES: Fax written comments on the
collection of information by January 14,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910—NEW and
title ‘‘Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850. 301–
796–3792. E-mail:
elizabeth.berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Guidance for Industry on Citizen
Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the
Federal Food, Drug, and Cosmetic Act
In the Federal Register of January 21,
2009 (74 FR 3611), FDA announced the
availability of a draft guidance for
industry entitled ‘‘Draft Guidance for
PO 00000
Frm 00047
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Sfmt 4703
78249
Industry on Citizen Petitions and
Petitions for Stay of Action Subject to
Section 505(q) of the Federal Food,
Drug, and Cosmetic Act’’ (FD&C Act).
FDA is now in the process of finalizing
this guidance. In that Federal Register
notice, FDA provided the public with 60
days to comment on the proposed
collection of information. FDA received
no comments pertaining to the
information collection in the draft
guidance.
Description of Respondents:
Respondents to this collection of
information as it is related to citizen
petitions are individuals or households,
State or local governments, not-forprofit institutions, and businesses or
other for-profit institutions or groups.
Respondents to this collection of
information as it is related to petitions
for stay of Agency action are persons
who choose to file a petition for an
administrative stay of action.
Burden Estimate: Section 505(q)(1)(H)
of the FD&C Act requires that citizen
petitions and petitions for stay of
Agency action that are subject to section
505(q) include a certification to be
considered for review by FDA. Section
505(q)(1)(I) of the FD&C Act requires
that supplemental information or
comments to such citizen petitions and
petitions for stay of Agency action
include a verification to be accepted for
review by FDA. This guidance describes
our current thinking on the
interpretation of these requirements.
The guidance sets forth the criteria the
Agency will use in determining if the
provisions of section 505(q) apply to a
particular citizen petition or petition for
stay of agency action. One of the criteria
for a citizen petition or petition for stay
of Agency action to be subject to section
505(q) of the FD&C Act is that a related
ANDA or 505(b)(2) application is
pending at the time the citizen petition
or petition for stay is submitted.
Because petitioners or commenters may
not be aware of the existence of a
pending ANDA or 505(b)(2) application,
the guidance recommends that all
petitioners challenging the
approvability of a possible ANDA or
505(b)(2) application include the
certification required in section
505(q)(1)(H) of the FD&C Act and that
petitioners and commenters submitting
supplements or comments, respectively,
to a citizen petition or petition for stay
of action challenging the approvability
of a possible ANDA or 505(b)(2)
application include the verification
required in section 505(q)(1)(I) of the
FD&C Act. The guidance also
recommends that if a petitioner submits
a citizen petition or petition for stay of
Agency action that is missing the
E:\FR\FM\15DEN1.SGM
15DEN1
78250
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
required certification but is otherwise
within the scope of section 505(q) of the
FD&C Act and the petitioner would like
FDA to review the citizen petition or
petition for stay of Agency action, the
petitioner should submit a letter
withdrawing the deficient petition and
submit a new petition that contains the
required certification.
FDA currently has OMB approval for
the collection of information entitled,
‘‘General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions’’ (OMB Control
Number 0910–0183). This collection of
information includes, among other
things: (1) The format and procedures
by which an interested person may
submit to FDA, in accordance with
§ 10.20 (21 CFR 10.20), a citizen petition
requesting the Commissioner of Food
and Drugs (Commissioner) to issue,
amend, or revoke a regulation or order,
or to take or refrain from taking any
other form of administrative action
(§ 10.30(b) (21 CFR 10.30(b))); (2) the
submission of written comments on a
filed citizen petition (§ 10.30(d)); (3) the
submission of a supplement or
amendment to or a letter to withdraw a
filed citizen petition (§ 10.30(g)); (4) the
format and procedures by which an
interested person may request, in
accordance with § 10.20, the
Commissioner to stay the effective date
of any administrative action (§ 10.35(b)
(21 CFR 10.35(b))); and (5) the
submission of written comments on a
filed petition for administrative stay of
action (§ 10.35(c)). This information
collection includes citizen petitions,
petitions for administrative stay of
action, comments to petitions,
supplements to citizen petitions, and
letters to withdraw a citizen petition, as
described previously in this document,
that are subject to section 505(q) of the
FD&C Act and described in the
guidance.
Under section 505(q) of the FD&C Act
and the guidance, the following
information would be submitted to FDA
but is not currently approved by OMB
under the PRA:
1. The certification required under
section 505(q)(1)(H) of the FD&C Act for
citizen petitions that are subject to
section 505(q) and/or that are
challenging the approvability of a
possible ANDA or 505(b)(2) application.
Although the submission of a
certification for citizen petitions is
approved under OMB Control Number
0910–0183, the certification would be
broadened under section 505(q) of the
FD&C Act and the guidance.
2. The certification required under
section 505(q)(1)(H) of the FD&C Act for
petitions for stay of Agency action that
are subject to section 505(q) and/or that
are challenging the approvability of a
possible ANDA or 505(b)(2) application.
3. The verification required under
section 505(q)(1)(I) of the FD&C Act for
comments to citizen petitions.
4. The verification required under
section 505(q)(1)(I) of the FD&C Act for
comments to petitions for stay of
Agency action.
5. The verification required under
section 505(q)(1)(I) of the FD&C Act for
supplements to citizen petitions.
6. Supplements to petitions for stay of
Agency action.
7. The verification required under
section 505(q)(1)(I) of the FD&C Act for
supplements to petitions for stay of
Agency action.
8. The letter submitted by a petitioner
withdrawing a deficient petition for stay
of Agency action that is missing the
required certification but is otherwise
within the scope of section 505(q) of the
FD&C Act.
Section 505(q)(1)(B) and (C) of the
FD&C Act and the guidance state that if
FDA determines that a delay in approval
of an ANDA or 505(b)(2) application is
necessary based on a petition subject to
section 505(q), the applicant may
submit to the petition docket
clarifications or additional data to allow
FDA to review the petition promptly.
This information collection is not
included in this analysis because it is
approved under OMB Control Number
0910–0001 (21 CFR 314.54, 314.94, and
314.102).
Based on FDA’s knowledge of citizen
petitions and petitions for stay of
Agency action subject to section 505(q)
of the FD&C Act that have been
submitted to FDA, as well as the
Agency’s familiarity with the time
needed to prepare a supplement, a
certification, and a verification.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency per
response
Number of
respondents
hsrobinson on DSK69SOYB1PROD with NOTICES
Certification for citizen petitions (505(q)(1)(H)) .........
Certification for petitions for stay of Agency action
(505(q)(1)(H)) .........................................................
Verification for comments to citizen petitions
(505(q)(1)(I)) ...........................................................
Verification for comments to petitions for stay of
Agency action (505(q)(1)(I)) ...................................
Verification for supplements to citizen petitions
(505(q)(1)(I)) ...........................................................
Supplements to petitions for stay of Agency action ..
Verification for supplements to petitions for stay of
Agency action (505(q)(1)(I)) ...................................
Letter withdrawing a petition for stay of Agency action ..........................................................................
Total Hours .........................................................
1 There
19
Total
annual
responses
1.32
Hours per
response
25
0.5
12.5
3
0.5
1.5
12
0.5
6.0
2
0.5
1.0
10
1
0.5
6.0
5.0
6.0
3
1
9
1.33
2
1
7
1
1.43
1
1
1
1
0.5
0.5
1
1
1
0.5
0.5
33
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–31380 Filed 12–14–10; 8:45 am]
BILLING CODE P
Generic Food and Drug Administration
Rapid Response Surveys—(OMB
Control Number 0910–0500)—Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0380]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Food and
Drug Administration Rapid Response
Surveys
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 14,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0500. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850. 301–796–
5156. Daniel.Gittleson@fda.hhs.gov.
SUMMARY:
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 355), requires that important
safety information relating to all human
prescription drug products be made
available to FDA so that it can take
appropriate action to protect the public
health when necessary. Section 702 of
the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for
enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C.
360i), FDA is authorized to require
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions to FDA; to require user
facilities to report device-related deaths
directly to FDA and to manufacturers;
and to report serious injuries to the
manufacturer. Section 522 of the FD&C
Act (21 U.S.C. 360l) authorizes FDA to
require manufacturers to conduct
postmarket surveillance of medical
devices. Section 705(b) of the FD&C Act
(21 U.S.C. 375(b)) authorizes FDA to
collect and disseminate information
regarding medical products or cosmetics
in situations involving imminent danger
to health or gross deception of the
consumer. Section 903(d)(2) of the
FD&C Act (21 U.S.C. 393(d)(2))
authorizes the Commissioner of Food
and Drugs to implement general powers
(including conducting research) to carry
out effectively the mission of FDA.
These sections of the FD&C Act enable
FDA to enhance consumer protection
from risks associated with medical
products usage that are not foreseen or
apparent during the premarket
notification and review process. FDA’s
regulations governing application for
Agency approval to market a new drug
(21 CFR part 314) and regulations
78251
governing biological products (21 CFR
part 600) implement these statutory
provisions. Currently, FDA monitors
medical product related postmarket
adverse events via both the mandatory
and voluntary MedWatch reporting
systems using FDA Forms 3500 and
3500A (OMB control number 0910–
0291) and the vaccine adverse event
reporting system. FDA is seeking OMB
clearance to collect vital information via
a series of rapid response surveys.
Participation in these surveys will be
voluntary. This request covers rapid
response surveys for community based
health care professionals, general type
medical facilities, specialized medical
facilities (those known for cardiac
surgery, obstetrics/gynecology services,
pediatric services, etc.), other health
care professionals, patients, consumers,
and risk managers working in medical
facilities. FDA will use the information
gathered from these surveys to obtain
quickly vital information about medical
product risks and interventions to
reduce risks so the Agency may take
appropriate public health or regulatory
action including dissemination of this
information as necessary and
appropriate.
FDA projects 6 emergency risk related
surveys per year with a sample of
between 50 and 10,000 respondents per
survey. FDA also projects a response
time of 0.5 hours per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
may be able to obtain by working with
health care professional organizations.
The annual number of surveys was
determined by the maximum number of
surveys per year FDA has ever
conducted under this collection.
In the Federal Register of August 6,
2010 (75 FR 47599), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency per
response
Total annual
responses
Hours per
response
Total
hours
10,000 ..............................................................................................................
hsrobinson on DSK69SOYB1PROD with NOTICES
Number of
respondents
26
60,000
.5
30,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Maximum.
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19:10 Dec 14, 2010
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]]>Agencies
[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78249-78251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31380]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0008]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Citizen Petitions and Petitions for Stay of Action Subject to
Section 505(q) of the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).
DATES: Fax written comments on the collection of information by January
14, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910--NEW and
title ``Guidance for Industry on Citizen Petitions and Petitions for
Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act.'' Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850. 301-796-3792. E-mail:
elizabeth.berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry on Citizen Petitions and Petitions for Stay of
Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act
In the Federal Register of January 21, 2009 (74 FR 3611), FDA
announced the availability of a draft guidance for industry entitled
``Draft Guidance for Industry on Citizen Petitions and Petitions for
Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and
Cosmetic Act'' (FD&C Act). FDA is now in the process of finalizing this
guidance. In that Federal Register notice, FDA provided the public with
60 days to comment on the proposed collection of information. FDA
received no comments pertaining to the information collection in the
draft guidance.
Description of Respondents: Respondents to this collection of
information as it is related to citizen petitions are individuals or
households, State or local governments, not-for-profit institutions,
and businesses or other for-profit institutions or groups. Respondents
to this collection of information as it is related to petitions for
stay of Agency action are persons who choose to file a petition for an
administrative stay of action.
Burden Estimate: Section 505(q)(1)(H) of the FD&C Act requires that
citizen petitions and petitions for stay of Agency action that are
subject to section 505(q) include a certification to be considered for
review by FDA. Section 505(q)(1)(I) of the FD&C Act requires that
supplemental information or comments to such citizen petitions and
petitions for stay of Agency action include a verification to be
accepted for review by FDA. This guidance describes our current
thinking on the interpretation of these requirements. The guidance sets
forth the criteria the Agency will use in determining if the provisions
of section 505(q) apply to a particular citizen petition or petition
for stay of agency action. One of the criteria for a citizen petition
or petition for stay of Agency action to be subject to section 505(q)
of the FD&C Act is that a related ANDA or 505(b)(2) application is
pending at the time the citizen petition or petition for stay is
submitted. Because petitioners or commenters may not be aware of the
existence of a pending ANDA or 505(b)(2) application, the guidance
recommends that all petitioners challenging the approvability of a
possible ANDA or 505(b)(2) application include the certification
required in section 505(q)(1)(H) of the FD&C Act and that petitioners
and commenters submitting supplements or comments, respectively, to a
citizen petition or petition for stay of action challenging the
approvability of a possible ANDA or 505(b)(2) application include the
verification required in section 505(q)(1)(I) of the FD&C Act. The
guidance also recommends that if a petitioner submits a citizen
petition or petition for stay of Agency action that is missing the
[[Page 78250]]
required certification but is otherwise within the scope of section
505(q) of the FD&C Act and the petitioner would like FDA to review the
citizen petition or petition for stay of Agency action, the petitioner
should submit a letter withdrawing the deficient petition and submit a
new petition that contains the required certification.
FDA currently has OMB approval for the collection of information
entitled, ``General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions''
(OMB Control Number 0910-0183). This collection of information
includes, among other things: (1) The format and procedures by which an
interested person may submit to FDA, in accordance with Sec. 10.20 (21
CFR 10.20), a citizen petition requesting the Commissioner of Food and
Drugs (Commissioner) to issue, amend, or revoke a regulation or order,
or to take or refrain from taking any other form of administrative
action (Sec. 10.30(b) (21 CFR 10.30(b))); (2) the submission of
written comments on a filed citizen petition (Sec. 10.30(d)); (3) the
submission of a supplement or amendment to or a letter to withdraw a
filed citizen petition (Sec. 10.30(g)); (4) the format and procedures
by which an interested person may request, in accordance with Sec.
10.20, the Commissioner to stay the effective date of any
administrative action (Sec. 10.35(b) (21 CFR 10.35(b))); and (5) the
submission of written comments on a filed petition for administrative
stay of action (Sec. 10.35(c)). This information collection includes
citizen petitions, petitions for administrative stay of action,
comments to petitions, supplements to citizen petitions, and letters to
withdraw a citizen petition, as described previously in this document,
that are subject to section 505(q) of the FD&C Act and described in the
guidance.
Under section 505(q) of the FD&C Act and the guidance, the
following information would be submitted to FDA but is not currently
approved by OMB under the PRA:
1. The certification required under section 505(q)(1)(H) of the
FD&C Act for citizen petitions that are subject to section 505(q) and/
or that are challenging the approvability of a possible ANDA or
505(b)(2) application. Although the submission of a certification for
citizen petitions is approved under OMB Control Number 0910-0183, the
certification would be broadened under section 505(q) of the FD&C Act
and the guidance.
2. The certification required under section 505(q)(1)(H) of the
FD&C Act for petitions for stay of Agency action that are subject to
section 505(q) and/or that are challenging the approvability of a
possible ANDA or 505(b)(2) application.
3. The verification required under section 505(q)(1)(I) of the FD&C
Act for comments to citizen petitions.
4. The verification required under section 505(q)(1)(I) of the FD&C
Act for comments to petitions for stay of Agency action.
5. The verification required under section 505(q)(1)(I) of the FD&C
Act for supplements to citizen petitions.
6. Supplements to petitions for stay of Agency action.
7. The verification required under section 505(q)(1)(I) of the FD&C
Act for supplements to petitions for stay of Agency action.
8. The letter submitted by a petitioner withdrawing a deficient
petition for stay of Agency action that is missing the required
certification but is otherwise within the scope of section 505(q) of
the FD&C Act.
Section 505(q)(1)(B) and (C) of the FD&C Act and the guidance state
that if FDA determines that a delay in approval of an ANDA or 505(b)(2)
application is necessary based on a petition subject to section 505(q),
the applicant may submit to the petition docket clarifications or
additional data to allow FDA to review the petition promptly. This
information collection is not included in this analysis because it is
approved under OMB Control Number 0910-0001 (21 CFR 314.54, 314.94, and
314.102).
Based on FDA's knowledge of citizen petitions and petitions for
stay of Agency action subject to section 505(q) of the FD&C Act that
have been submitted to FDA, as well as the Agency's familiarity with
the time needed to prepare a supplement, a certification, and a
verification.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
Certification for citizen 19 1.32 25 0.5 12.5
petitions (505(q)(1)(H))...
Certification for petitions 3 1 3 0.5 1.5
for stay of Agency action
(505(q)(1)(H)).............
Verification for comments to 9 1.33 12 0.5 6.0
citizen petitions
(505(q)(1)(I)).............
Verification for comments to 2 1 2 0.5 1.0
petitions for stay of
Agency action
(505(q)(1)(I)).............
Verification for supplements 7 1.43 10 0.5 5.0
to citizen petitions
(505(q)(1)(I)).............
Supplements to petitions for 1 1 1 6.0 6.0
stay of Agency action......
Verification for supplements 1 1 1 0.5 0.5
to petitions for stay of
Agency action
(505(q)(1)(I)).............
Letter withdrawing a 1 1 1 0.5 0.5
petition for stay of Agency
action.....................
Total Hours............. ............... .............. ............... ............... 33
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 78251]]
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
[FR Doc. 2010-31380 Filed 12-14-10; 8:45 am]
BILLING CODE P
